Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease

August 20, 2025 updated by: China National Center for Cardiovascular Diseases
This study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (ARNI) on improving ischemic mitral regurgitation (IMR) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) through a randomized controlled clincial trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Recruiting
        • China National Center for Cardiovascular Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Fully informed and voluntarily signed informed consent;
  2. Received CABG and moderate IMR was diagnosed on two consecutive preoperative transthoracic echocardiography (according to 2021 ESC/EACTS Guidance Standards )

Exclusion Criteria:

1.Symptomatic hypotension and/or a SBP < 100 mmHg at screening; 2.Estimated GFR < 30 mL/min/1.73m2; 3.Serum potassium > 5 mmol/L at screening; 4.History of angioedema or unacceptable side effects while receiving ACE inhibitors or ARBs; 5.Patients receiving mitral valve intervention at the same time, or have participated in other clinical trials, or are unwilling to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group: isolated CABG
Experimental: Sacubitril/valsartan therapy after isolated CABG
Drug: sacubitril/valsartan
Sacubitril/valsartan therapy after isolated CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective regurgitant orifice area (EROA)
Time Frame: 6 months postoperatively
Change in EROA of mitral regurgitation evaluated by echocardiography from baseline to 6 months follow-up
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients with moderate or higher IMR ,LVEF,LVESV,LVESVI,LVEDV,LVEDVI
Time Frame: 6 months postoperatively
Proportion of patients with moderate or higher IMR; Left ventricular ejection fraction; Change of left ventricular end-systolic volume from baseline to 6 months follow-up; Change of left ventricular end-systolic volume index from baseline to 6 months follow-up; Change of left ventricular end-diastolic volume from baseline to 12 months follow-up; Change of left ventricular end-diastolic volume index from baseline to 12 months follow-up
6 months postoperatively
major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: 6 months postoperatively
major adverse cardiovascular and cerebrovascular events (MACCE) defined as the composite of all-cause death, stroke, myocardial infarction, rehospitalization for heart failure, and repeat mitral valve surgery.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences

Investigators

  • Study Chair: Wei Zhao, China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-I2M-C&T-B-070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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